Taiwan Diagnostic and Monitoring Devices Market Size and Forecast by Offering, Technology, Clinical Application, Distribution Channel, and End User: 2019-2033

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Industry Assessment Overview

Industry Findings: Taiwan’s regulatory precision and emphasis on telehealth standards are changing buyer preferences toward validated remote-monitoring devices and locally certificated IVDs. TFDA’s consolidated device licensing and border-inspection regulations (published in Nov-2023) have tightened registration details and raised expectations for conformity and post-market reporting, making local regulatory-ready suppliers more attractive to Taiwanese hospitals and exporters seeking stable market access.

Industry Progression: The TFDA’s recent focus on AI and software-driven devices accelerated with new technical guidance for AI-based CADe/CADx systems (Aug-2025), clarifying inspection and registration requirements for machine-learning solutions. The guidance made the approval path clearer for AI imaging and decision-support vendors and nudged hospitals to pilot certified AI tools linked to imaging and monitoring workflows.

Industry Player Insights: The market comprises many players, and a small portion of them includes TaiDoc, Microlife, Roche Diagnostics, and Abbott etc. Domestic telehealth and device makers are expanding capability: TaiDoc’s telehealth and remote-monitoring product suite (2024–2025) and Microlife’s continued device availability support rising home-care demand. Combined with Roche and Abbott’s diagnostic franchises, these vendor activities accelerate adoption of validated POC and remote devices across Taiwan’s clinics and long-term care networks.